A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC

NCT06439771 | Recruiting Phase 2 FDA Drug

• 1 other identifier: YL202-CN-202-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive, HER2-zero-expression or HER2-low-expression

Conditions

Locally Advanced or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

• ORR assessed according to RECIST v1.1

  ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).

  By the end of trial date, approximately within 36 months

• Determination of the recommended dose of YL202 in the pivotal clinical study

  By the end of trial date, approximately within 36 months

Secondary Outcomes (16)

• Progression-free survival (PFS) assessed according to RECIST v1.1

  By the end of trial date, approximately within 36 months

• Clinical benefit rate (CBR) assessed based on RECIST v1.1

  By the end of trial date, approximately within 36 months

• Depth of response (DpR) assessed based on RECIST v1.1

  By the end of trial date, approximately within 36 months

• Disease control rate (DCR) assessed based on RECIST v1.1

  By the end of trial date, approximately within 36 months

• Duration of response (DOR) assessed based on RECIST v1.1

  By the end of trial date, approximately within 36 months

Study Arms (3)

Experimental: Corhort A

EXPERIMENTAL

YL202 is provided as the lyophilized powder, 200 mg/vial. Triple-negative breast cancer (TNBC) patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.

Drug: YL202 should be intravenously infused

Experimental: Corhort B

EXPERIMENTAL

YL202 is provided as the lyophilized powder, 200 mg/vial. HR-positive breast cancer with HER2-Zero-expression and HER2-Low-expression patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.

Drug: YL202 should be intravenously infused

Experimental: Corhort C

EXPERIMENTAL

YL202 is provided as the lyophilized powder, 200 mg/vial. Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC (excluding HER2+ patients, ie, HER2 IHC 3+ or IHC 2+/ISH+ patients) will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.

Drug: YL202 should be intravenously infused

Interventions

YL202 should be intravenously infused DRUG

For each patient, YL202 should be intravenously infused over 60±10 min.

Experimental: Corhort A; Experimental: Corhort B; Experimental: Corhort C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.
• Patients with locally advanced or metastatic disease (according to the UICC and AJCC staging system \[Version 8\]) who are not candidates for curative surgery or radiotherapy.
• Patients who are pathologically confirmed advanced/unresectable or metastatic breast cancer with HR-negative and HER2-negative,.
• Patients who are confirmed HR positive and HER2-Zero-expression and HER2-Low-expression.
• Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC.
• Have at least 1 extracranial measurable lesion as a target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Have Adequate organ and bone marrow function within 7 days prior to the first dose.
• Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug.
• Have a expected survival ≥ 3 months.
• Have ability and willingness to comply with protocol-specified visits and procedures.

You may not qualify if:

• Have prior treatment with an agent targeting HER3.
• Have prior intolerance to treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.
• Have been enrolled in another clinical study concurrently unless it is an observational clinical study or in the follow-up phase of an interventional study.
• Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.
• Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the study.
• Have prior allogeneic bone marrow transplant or prior solid organ transplant.
• Have received treatment with systemic steroids.
• Have received any live vaccine within 4 weeks prior to the first dose of study drug or intend to receive a live vaccine during the study.
• Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.
• Brain metastases with the exceptions.
• Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease.
• Have clinically significant concomitant pulmonary diseases.
• Have a diagnosis of Gilbert's syndrome.
• Have pleural effusion, abdominal effusion.
• Have a history of gastrointestinal perforation and or fistula within 6 months prior to the first dose.

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 250117, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

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CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: June 3, 2024
• Study Start: April 23, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 29, 2028
• Last Updated: November 15, 2024

Record last verified: 2024-06

Locations

CN (1)